Identity
- Trade Name
- First EUDAMED
- Model / Reference
- BU00003 EUDAMEDMF92140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05690977569874 EUDAMED
- Basic UDI-DI
- 5690967BU00003MX EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Mechanical-resistance external ankle-foot prosthesis
First by Össur Iceland ehf. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Mechanical-resistance external ankle-foot prosthesis.
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- Soleus — COLLEGE PARK INDUSTRIES, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5690967BU00003MX | Class I | Active |
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Manufacturer
- Manufacturer
- Össur Iceland ehf.
- EUDAMED SRN
- IS-MF-000000173
Sources (1)
- EUDAMED ca84e0b7-4a1a-4a36-998e-bd9ddad83e47 61 fields · synced Sep 18, 2026